Method and apparatus for verification of medication administration adherence

ABSTRACT

A system and method of confirming administration of medication is provided. The method comprises the steps of receiving information identifying a particular medication prescription regimen, determining one or more procedures for administering such prescription regimen and identifying one or more activity sequences associated with such procedures. Activity sequences of actual administration of such prescription regimen are captured and then compared to the identified activity sequences to determine differences therebetween. A notice is provided if differences are determined.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Pat. Application Serial No.17/179,277, filed Feb. 18, 2021 to Hanina et al., entitled “Method andApparatus for Verification of Medication Administration Adherence,”which is a continuation of U.S. Pat. Application Serial No. 16/530,073,filed Aug. 2, 2019 to Hanina et al., entitled “Method and Apparatus forVerification of Medication Administration Adherence,” now U.S. Pat. No.10,929,983, issued Feb. 23, 2021, which, in turn, is a continuation ofU.S. Pat. Application Serial No. 14/989,179, filed Jan. 6, 2016 toHanina et al., entitled “Method and Apparatus for Verification ofMedication Administration Adherence,” now U.S. Pat. No. 10,402,982,issued Sep. 3, 2019, which, in turn, is a continuation of U.S. Pat.Application Serial No. 14/295,485, filed Jun. 4, 2014, to Hanina et al.,entitled “Method and Apparatus for Verification of MedicationAdministration Adherence,” now U.S. Pat. No. 10,297,030, issued May 21,2019, which, in turn, is a continuation of U.S. Pat. Application SerialNo. 13/558,377, filed Jul. 26, 2012, to Hanina et al., entitled “Methodand Apparatus for Verification of Medication Administration Adherence”,now U.S. Pat. No. 8,781,856, issued Jul. 15, 2014, which, in turn, is acontinuation of U.S. Pat. Application Serial No. 12/620,686, filed Nov.18, 2009, to Hanina et al., entitled “Method and Apparatus forVerification of Medication Administration Adherence,” currentlyabandoned. The contents of all of the prior applications areincorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

It has been widely recognized that methods and systems for ensuringproper medication ingestion by individuals are very important indefending against unnecessary sickness, deaths and other problems.Giving instructions and then letting patients fend for themselves hasbeen shown not to work particularly well. This is because it is not onlythe improper ingestion of medicines that is the primary cause of medicaldanger. Rather, an overall lack of sufficient patient guidance is partof the problem. Also, the inability to confirm a proper prescriptionregimen being provided to a user in the first place may cause a numberof other problems with the use of such medication. While other systemshave been proposed to ensure such proper usage of medication, it is onlythe present invention that provides a complete solution to themedication management problem.

Dr Lars Osterberg, M.D. and Dr, Terence Blaschke have reported in theNew England Journal of Medicine, Adherence to Medication, (N Engl J Med2005; 353:487-97) 2005 an alarming lack of adherence to requiredmedication protocol, further noting that while the average rates ofadherence in even clinical trials is “high”, this number still comprisesonly rates of 43 to 78 percent. Most importantly, the authors note “Theability of physicians to recognize nonadherence is poor, andinterventions to improve adherence have had mixed results.” Adherence,p. 487.The authors conclude “Poor adherence to medication regimens iscommon, contributing to substantial worsening of disease, death andincreased healthcare costs.” Adherence, p. 494. The Trend Repot Series,2008 Patient Adherence Update: New Approaches for Success, October 2008,report similar discouraging statistics. It is against this backdrop ofpoor adherence, and potential danger to patients, that the presentinvention operates.

A number of systems exist that provide instructions to a user regardingwhen to take a medication and records when the user indicates that amedication has been taken. U.S. Pat. No. 7,359,214 describes such asystem. A device is provided that provides instruction to a patientregarding medications to take. Furthermore, the system may provide amethod for determining that the prescription is appropriate given thepatient’s conditions, and other medications he or she may already betaking. The system may also provide a method for monitoring complianceof the patient with such a regimen, through the dispensing of medicinein accordance with a predetermined treatment protocol. While such asystem provides many improvements for easing a burden on the patient,this system suffers in many ways.

Most importantly, this system provides no mechanism for actuallyconfirming that a patient is in fact ingesting or otherwise properlyadministering required medication. While the system may be sufficientfor one who is in full possession of their mental faculties, anyindividual who may have difficulty following directions, or one who isactively avoiding medication may still not be taking required medicationafter it is dispensed. Furthermore, the system requires preloading ofvarious medications into a dispenser, and thus likely requires regularvisits by an administering manager to be sure appropriate medicationsare in fact loaded therein. It is surely possible that an inexperienceduser may place incorrect medications into the device, or may somehowprovide incorrect dosages into the device. Additionally, for potentiallymore complex regimens, there is no method provided for ensuring that auser is able to follow such a protocol, and to thereafter confirm thatthe user has in fact taken all required medications in accordance withany provided instructions or the like, or has taken the medicationsaccording to one or more specifications or followed suggestedprocedures.

U.S. Pat. Application Serial No. 11/839,723, filed Aug. 16, 2007, titledMobile Wireless Medication Management System provides a medicationmanagement system employing mobile devices and an imaging technology sothat a user is able to show a pill to be taken to the system, and thesystem can then identify the medication. Patient histories are availableto an administrator, including various vital signs as measured by thesystem. Images may also be taken of the patient, provider, medicationcontainer or the like. While the system professes to ensure adherence toa protocol, the system only provides such help if requested by a user.There is in fact no particular manner in which to ensure actualadherence or the relationship of adherence to the efficacy of the drugover time. When customizing a medication regimen or monitoring apersonal medication regimen, this is particularly relevant.

Additionally, existing systems fail to maintain an audit trail for postadministration review by a medical official, and further cannottherefore confirm confirmation of proper medication administration.Existing systems are further generally impractical in that they fail toaddress many of a patient’s other healthcare needs, including billing,insurance paperwork and filing, education regarding healthy living andproper use of medications, easing obtaining refills for medications, andproviding feedback to a medical service provider, for example, inadvance of an appointment so that the medical provider can be preparedfor such an appointment.

Therefore, it would be desirable to provide a method and apparatus thatovercomes the drawbacks of the prior art.

SUMMARY OF THE INVENTION

In accordance with the present invention, a system and method areprovided that allow for complete control and verification of adherenceto a prescribed medication protocol, whether is a health care provider’scare, or when self administered in a homecare situation by a patient.The system and method preferably includes a means for receiving usermedication information, including a medication profile and history,providing indications to a user regarding when to take a medication, andwhich medication to take, imaging medication either in pill or containerform to confirm a correct medication is being taken, confirming, inaccordance with the user medication history that a new medication willnot conflict with an already being taken medication (includingnon-prescription medication that may be used by a patient), scan a groupof medication containers or pills to inform a user which is the correctmedication through the use of visual, verbal or other prompts, providingassistance information to aid a user in properly taking the medication,imaging, employing still photos, video sequences or other activity orgesture recognition techniques, the user to confirm that the medicationis being actually and properly taken, providing any appropriateadditional or special instructions, using the imaging to note anypossible adverse effects associated with taking of the medication,accumulating statistics about adherence to a prescribed protocol,assisting in reordering medication on an as-needed basis and notifying amedical professional if the user is not properly following a prescribedprotocol.

From beginning to end, a user is provided with a system and method thataids the user in properly following a protocol, while informing anadministrator of any deviations from the protocol, either innocent orpurposeful, by a user so that an early interaction may be provided. Thepresent invention is the only medication adherence verification systemthat may determine whether a user is actually following a protocol, andprovide additional assistance to a user, starting with instructions,video instructions, and the like, and moving up to contact from amedication administrator through phone, email video conferencing or thelike, if it is determined that the user may benefit from suchassistance. Upon prescription of a medication to a user and entry ofappropriate medical information into the system, the pharmacist or othermedical personnel may allow the system to image the medication or entermedication information in any number of ways, thus recalling one or morepreferred protocols for administration of the medication. An image ofthe medication may be further provided to the pharmacist upon this orany subsequent refills of the medication and act as an added visualcheck to confirm proper medication administration. The personnel maythen select a desired protocol, thus removing a likely point of error,incorrect instructions to a user. Further, a medication image may beshown to a patient when they are to take a medication, to thus furtherensure proper medication is administered.

Further in accordance with the invention, access to such medicationinformation may be made available to emergency responders, hospital orother medical service providers or the like. It is contemplated thatsuch information may be available by entering a predefined sequence intoa patient’s cellular telephone, other mobile device, or home basedsystem. Further access may be provided at a predetermined website or thelike.

Still other objects and advantages of the invention will in part beobvious and will in part be apparent from the specification anddrawings.

The invention accordingly comprises the several steps and the relationof one or more of such steps with respect to each of the others, and theapparatus embodying features of construction, combinations of elementsand arrangement of parts that are adapted to affect such steps, all asexemplified in the following detailed disclosure, and the scope of theinvention will be indicated in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the invention, reference is made tothe following description and accompanying drawings, in which:

FIG. 1 is a flow chart diagram depicting top level functionality inaccordance with an embodiment of the present invention;

FIG. 2 is a flow chart diagram describing a data entry and prescriptionassignment process in accordance with an embodiment of the presentinvention; and

FIG. 3 is a flow chart diagram describing a medical compliance regimenfrom in accordance with an embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In accordance with the invention, a system and process are provided thatimprove adherence to medical protocol, and give administrators atangible and concrete manner in which to confirm compliance or lackthereof, and the ability to intervene early in the process to ensurethat patients are properly taking their medication. The system andmethod of the invention provide for prescription selection, instructionsto patients on the use of any prescription medications, and verificationto a doctor or other service provider of patient adherence to theprescribed protocol.

Referring first to FIG. 1 , a data flow overview is shown. In accordancewith the invention, existing industry medication information databases110 are employed to access prescription, interaction, application andother available information about any number of proposed prescriptionand non-prescription medications. Further, patient medical records 115are used, and as will be described below, are used in conjunction withthe industry medical information and a medical professional’sprescribing expertise to prescribe a medicine regimen, and enter such aregimen into the system of the invention at 120. Once entered into thesystem, a particular prescription regimen causes a set of userinstructions 125 to be generated. Such user instructions may includegeneral instructions about a particular medication, methods foringestion, concerns about side effects, concerns about drug interactionswith common substances or medications, or other medications prescribedto the patient by the system or by another medical service provider. Itis contemplated in accordance with the invention that such set of userinstructions may be interactive, allowing a user to view additionalinformation about such instructions or prescriptions as desired. Theseinstructions may comprise written, audio or video instructions.Furthermore, it is contemplated in accordance with the invention that atvarious points during the instruction set, for example when a patientasks a particular type of question, or asks to receive additionalinformation about a particular aspect of the medication or prescriptionregimen, that the system may reach out and contact a representative of amedical service provider to provide the patient with additional,personal help as necessary, if it is determined that such interventionby the medical professional would be desirable to the patient. Thus,such a patient may be assisted in properly taking medication so thatvarious errors do not take place. Indeed, in more traditional scenarios,it is only after perhaps finishing a prescription regimen and a returnto a doctor that it is discovered that the medication may have beentaken incorrectly. In accordance with the present invention, earlyintervention with such issues can be exercised to deter any possibleunfortunate outcomes from improper administration of medication. It iscontemplated in accordance with the invention that a medical serviceprovide or one of the individuals noted above be provided with a patientdashboard for managing prescription regimes for one or more patients.Such a dashboard allows the medical professional to monitor any numberof patients in a manner that will be described below, allow statisticalanalyses of patient adherence and other patient reactions, provide linksto information, including recorded activity sequences for one or morepatients, and generally allow the medical professional to monitor andadminister medication to all of their patients form a convenient singleaccess point. Such a dashboard also allows for monitoring of any healthcare providers that may be administering medication to a number ofpatients, or review of one or more administration sequences or the like.

Additionally, it is contemplated in accordance with the invention thatthe patient be provided with a user interface dashboard or the likeallowing of modification of prescription regimen and instructioninformation by the patient. Thus, by way of example, if a user is totake a particular medication before eating in the morning, the user maybe able to determine when a reminder for such medication will be given.If the patient is an early riser, the reminder may be provided by cellphone or email at 6:00AM. Conversely, if the patient sleeps late andnormally does not eat an early meal, reminders can be set for later inthe morning, thus matching a patient’s schedule. Of course, any suchpatient adjustments must be set within broader prescription regimen asdefined by the prescribing medical provider. It is contemplated inaccordance with the invention that a touch or other user friendlygraphical user interface be provided so that the user can easilymanipulate any number of prescription factors, and perhaps enteradditional information that may be useful to a prescribing medicalprovider, such as level of fatigue, level of hunger, jitter inducingmedications, etc. All of these data collection points allow for asmoother administration of medication to a patient, and therefore a morelikely chance of adherence to a prescribed protocol.

Referring to the portion of FIG. 1 , the horizontal line indicates atime for patient ingestion or other administration of medication. Inaccordance with the invention, confirmation of patient adherence to theprescribed administration schedule for the medication is determined.While such confirmation may take a number of forms, in accordance withthe invention, a preferred method for such confirmation may includecapturing a video sequence of the patient actually administering themedication. In a further preferred method, such a sequence for suchconfirmation may include employing a facial recognition sequence orother biometric confirmation that a particular patient is in factreceiving treatment. Activity recognition, gesture recognition or otherfeature for determining whether a particular subject movement meets apredefined movement sequence may be employed to be sure that the patientis properly taking prescribed medication. The patient may then display amedication container and/or an actual pill or other medication form toan imaging apparatus, and the apparatus confirming that the medicationis correct and is the currently prescribed medication to be takenthrough the user of text recognition, pill recognition, or otherappropriate medication recognition scheme. This sequence of stepstherefore acts as an audit trail each time a medication is taken, thatcan be reviewed later, to ensure that a patient is properly following aregimen.

Furthermore, in accordance with the present invention, a video image ofthe patient actually administering or ingesting the medication may betaken and stored so that actual confirmation may be achieved, ratherthan simply relying on the patient to state that a particular medicationwas administered. Such a video image may be captured or stored in anyappropriate format given a selected type of activity or gesturerecognition that is employed in accordance with a particular embodimentof the invention. Such may include full video, biometric data points,recording of movement of an article, such as a bracelet or the like,affixed to the patient or administrator, use of mapping to provide astick figure or other body movement tracking technique, or gesture oractivity recognition to determine movement or the like. Finally, inaccordance with the invention, if recording of a video of a patienthaving the medication administered thereto is not possible, the systemof the invention will recognize such an issue and request audioconfirmation as a next best option. If the audio confirmation is alsonot possible, then a less reliable method of confirmation, such as akeyboard confirmation by the patient may be accepted. If higherreliability methods of confirmation are not available for an extendedperiod of time, an alarm is preferably forwarded to a medicalprofessional to inquire as to reasons and to remedy any situation thatmight be wrong in the administration situation.

These steps of confirming identity, confirming medication and confirmingadministration are then reviewed to verify adherence to the prescribedprotocol at 135. Such review is preferably performed automatically by acomputing system that is able to align the actual recorded images withideal or expected images, or through the user of other activity orgesture recognition as mentioned above. In the case of facialrecognition and bottle or pill recognition, such techniques are known inthe art. With regard to video confirmation of adherence to prescribedmedicine administration procedures, such processing may include variousstick figure comparison analyses, motion recognition analysis, or otherschemes as noted above able to determine whether appropriate actionshave been performed by the patient.

The ability to provide automated determination of adherence to properadministration procedures allows for a large number of such images to bereview in a short period of time. Even if actual and complete lack ofadherence is not able to be determined 100% in each possible situation,the ability to pre screen the administration video captures to removefrom further consideration administration situations that are clearlycompliant may reduce a number of compliance situations to be reviewed bya medical professional substantially.

In an additional embodiment of the invention the imaged sequences usedfor activity recognition to determine regimen adherence may be furtherused to check for adverse or other reactions to taking of themedication. Thus, in addition to simply determining proper adherence toa protocol, such activity or gesture recognition may determine anynumber of different actions that may have been taken by a patient. Thus,actions taken before medication administration, or actions taken aftermedication administration may give insight into reasons for particularresponses, etc. Thus, before administration, in accordance with theinvention, activity recognition may determine a current activity of auser. Any subsequent reminders to take a medication may in part be basedupon this determined activity. By way of example, if a user is puttingon a coat, or is determined to be leaving a residence or other facilityor the like, a reminder to take a medication before leaving may beprovided, even if earlier than normal, or if medication is portable, theuser may be reminded to take the medication with them, and thensubsequently reminded to administer the medication via notification on amobile device. By way of further example, if the user is cooking, areminder may be given to take the medication a predetermined time beforeeating. Other scenarios may be possible, thus allowing greater responsefrom the system to ensure proper medication administration by a patient.Additionally, various patient consent issues may be prompted andrecorded in accordance with the invention. Patients may ask furtheradditional questions regarding such consent, thus ensuring that patientshave all of the information they need to make informed consentdecisions, and medication providers have proper evidence of suchconsent.

Similarly, actions after taking medication may give insight into patientresponses. Notice of fainting, falling down, lack of motion, facialgestures, gastrointestinal distress or the like may all be logged asadverse reactions to a particular medication regimen, and may allow foradjustment of dosage or prescription instructions in the future for thepatient. If adverse reactions are severe, an immediate medication reviewand contact from a medical professional may be provided to cure theissue. Additionally, the system in accordance with the present inventionmay be directly tied and be interoperable with a pharmacy or medicalprovider’s systems, thus allowing such recommendations for dosagechanges, regimen changes and the like to be forwarded to theseprofessionals automatically. Through such links, reordering medication,dosage changes, medication changes and the like may be automaticallyprovided. Furthermore, ease of providing additional prescriptions can beenhanced as patient, medication and regimen information will already beavailable to the pharmacist or medical service provider.

After such automatic, or combination of automatic and manual, adherenceverification is performed allowing a health care provider or othermedical professional to review and verify results of the automaticcomparison or direct review of captured activity sequences, andindication of variation from a desired identity, medication orapplication procedure may request administrator review of the situation,and intervention as may be determined necessary at 140. Such review maybe required immediately as an emergency situation may exist, or suchreview may be less urgent, perhaps requiring an electronic communicationwith suggestions or the like from such an administrator or the like.Additionally, such adherence review may be stored over time for aparticular patient, thus allowing for various medication trends to bedetermined, such as if a patient misses medication at a same time eachweek, or an indication that one particular health care worker aiding thepatient may occasionally give an incorrect medication dosage amount.Thus, in addition to allowing for immediate notice of problems inmedication administration, an audit trail for tracking the actions ofvarious health care providers is generated.

Therefore, in accordance with the invention as set forth in FIG. 1 , amethod and system are provided in which patient adherence to aprescribed medication regimen can be reviewed, acutely for a particularinstance, or over time to determine any changes in behavior of apatient. Because all aspects of such adherence are monitored preferablyvisually, and do not rely on patient confirmation of medicationadministration, desires of the patient are taken out of the equation,and a true review of actually procedures used in the medicationadministration can be studied.

Referring next to FIG. 2 , a more precise description of the data,medical record and prescription regimen entry will now be described. Asis shown in FIG. 2 , a number of entities may be able to enterinformation into a system in accordance with the invention. Suchindividuals may include a doctor 202, a pharmacist 204, a patient 206and a caregiver 208. Each of these individuals may be provided withdifferent rights for data entry. For example, a doctor may be providedwith the ability to alter patient information, basic medical statistics,and virtually all other medical information included in a database. Apharmacist may be limited to entering information about a particularprescription, including when delivered to a patient, type of pill ormedication, dosage size, refill availability, etc. A patient may belimited to providing personal information, and perhaps other relevantinformation, such as non-prescription medication usage, alcoholconsumption, recent symptoms, reaction to use of particular prescriptionmedications and the like. A caregiver may be limited to enteringinformation about patient reactions, times of administration ofmedication and the like. Such data entry allows for the tracking of anaudit trail at this step of administration as well.

Information from each user of the system is combined, where available,and formed into a prescription medication entry 210. In particular, apreferred list of information that may first be provided in accordancewith the invention in order to organize the system may comprise apatient name, a user name, if that user is not the patient, andinformation to be used to provide various alerts, such as a patientemail for prescription reminders, contact information for a doctor orcaregiver for emergency contact, or the like. In addition, in accordancewith the invention, facial images of the patient and other peopleinteracting with the system are stored, or other biometric identifiers,such as fingerprint identification, retinal identification, voicerecognition, various provided RFID tags or the like may be employed. Ofcourse, if the patient is a returning patient, such information may beextracted from an existing database stored with another, previousprescription.

Next, a user such as the doctor 202 or the pharmacist 204 may indicate aparticular new or recurring prescription medication to be provided to auser. An external medication database 215 is accessed and informationregarding such medication is provided, including medication name ornames if multiple brand and generic names exist, suggestions forappropriate prescription dosages based upon patient information and theparticular version of the medication to be administered, and usageinstructions to be provided to the patient, these instructions beingmodified or supplemented as necessary by the prescribing entity. Theseusage instructions preferably include detailed administrationinstructions, including time of day, patient status (i.e., before orafter eating, after waking, before sleeping, etc.), precise method ofapplication, and other useful instructions for a user. Theseinstructions also may include video sequences to describe particulardetails of the medication or administration procedure thereof. They mayalso comprise alternative versions of instructions so that if a user isunclear regarding a particular set of instructions, an alternative setof instructions may be provided to the patient to aid in adherence tothe prescription regimen.

After selection of such a medication, a patient medical history 217 ispreferably accessed to provide additional medication and patientinformation to the prescribing individual. Such information may include,other prescriptions to the patient so that adverse drug interaction maybe determined (although if such other prescriptions were implemented inaccordance with this invention, such prescriptions will already be knownto the system), patient indication of use of non-prescription drugs,patient allergies, patient activity level, past diseases and procedures,and any other information that may be relevant to the prescription ofmedication.

After all of the information has been entered about the user, andinformation from the medication and patient database has beenaccumulated, various medication interactions are checked automaticallyby the system at step 220. Any dangerous interactions are noted to theprescribing individual, and may preclude entry of the prescription intothe system. Other interactions may be noted to the prescribingindividual so that the individual may make the patient aware of suchsituations. These may include, for example a notification that thetaking of two medications together may result in stomach pains, so thatthe patient should take one in the morning and one in the afternoon.Such interactions check will then result in a set of instructions thatwill be provided to the user, in addition to the more generic medicationinstructions. Finally, the prescribing individual may review suchinstructions and supplement them as desired. It should be noted that inaccordance with the invention it is contemplated that variousinstructions provided to a user may comprise hot links to additionalaudio and visual information that may be provided to a patient tofurther assist in their adherence to any particular prescribed protocol,or may provide various information regarding the particular medicationbeing taken as will be further described below.

Finally, after all interactions and instructions have been reviewed andapproved, the prescription information is stored at step 225. Thestoring of such a prescription makes the prescription, alerts, helpinformation and the like accessible to a patient and other system users.Furthermore, such completion may also transmit the prescription to apharmacy or other medication provision facility so that the user is ableto simply swing by to pick up the medication or to have the medicationdelivered to the patient.

Referring next to FIG. 3 , a user implementation of the method inaccordance with the invention will be described. When a time forreceiving or administering a medication is reached, a patient, and anyother necessary user may be provided a notification 310 in accordancewith notification addresses entered in the system as noted above. Thus,in a home situation, only the patient may receive notification. If thereis a home health care provider, such provider may also receive separateindependent verification. In the case of hospital or other in-patientcare facility, various medical service providers may similarly receivesuch notification. After notification, or in the absence of suchnotification, system initiation takes place at 315. In accordance withsuch system initiation, one or more users are preferably recognized bythe system. Therefore, at step 320, a user recognition sequence takesplace. In a preferred embodiment, such a user has a still or video imagecaptured of their face, and facial recognition techniques are employedto confirm the identity of the user. Such capture may be performed byfixed camera, mobile camera, mobile communication device such as acellular phone, or any other appropriate video or image capture device.Alternative recognition techniques, such as retinal, fingerprint, voiceor other biometric measurements may be employed, in addition to a morecommon password query.

At step 325 it is determined whether all necessary users have beenrecognized and authenticated. In a situation where a nurse, doctor orother caregiver is to administer medication, it may be preferable tohave the patient and caregiver to be recognized by the system to furtherconfirm that the appropriate procedure is followed, and to allow thesystem to keep track of people using the medication so it can track ifany one person, for example, is improperly using the medication, as willbe evident from the generated audit trail. After step 325, if all usersare not recognized, control passes back to step 320 and any additionalusers are recognized by the system.

Once all users are recognized, control passes to step 327 where themedication to be administered in accordance with the prescribedprescription regimen is confirmed. Thus, a user is prompted to allow astill or video image, text recognition image, or other method ofidentifying a medication to be captured of the medication bottle orother container, a pill of the medication, or other form of medication,and is also able to determine appropriate quantities, dosage, and anypotentially required or dangerous medication combinations. As notedabove, if video confirmation is for some reason not available, the usermay be prompted by the system to provide audio or other indication ofmedication and other desired information. This image, video sequence orother received confirmation information is then compared to an imageassociated with the prescription as noted above in FIG. 2 . If themedication is determined to be incorrect, a warning may be provided tothe user that the medication is incorrect. The user may then be promptedto choose another medication for imaging.

Alternatively, the invention contemplates a user displaying a number ofmedications to the image capture apparatus and allowing the apparatus tosuggest which medication is correct. Thus, the user may be able to scana medicine cabinet with such a video imaging apparatus and have thesystem indicate which is the correct medication. This may prove valuablewhen sequence of ingesting medication is important, or when two peoplehave similar medications and may have difficulty in distinguishingbetween medications for each. Once a correct medication has beenidentified, control passes to step 330.

In step 330 user prompts and other instructions are provided to thepatient, and present caregivers, as to how to administer the medicationaccording to the prescription guidelines outlined above. Theseinstructions allow for a user to receive further information orinstructions as necessary through asking the system for additional help.Especially in situations where an elaborate scheme may be required, itis contemplated that video samples and instructions may be provided tothe user. Further, in accordance with the invention, for complicatedadministration procedures, it may be possible to set up a two way videoconference employing traditional video conferencing, VOIP conferencing,traditional telephone conferencing, or any other appropriatecommunication system with an expert in such administration so that acaregiver or patient may receive live coaching regarding suchadministration.

When following such instruction prompts, the actual act ofadministration is preferably captured as a video sequence at step 335.This captured video sequence may be utilized in accordance with theinvention in a number of ways. First, the actions of administration ofthe medication is reviewed in real time and compared to an ideal ordesired video sequence. If a determination is made that the medicationis being administered in an incorrect manner, and in a way that may bedetrimental to the patient, immediate warnings may be provided at step340 advising the caregiver or patient to stop administration at once.Furthermore, in extreme cases, a doctor or other caregiver may benotified, or in the most dangerous cases, an ambulance or otheremergency personnel may be dispatched to provide immediate care. Ifvideo recording is not available, other confirmation methods as notedabove may be employed and be subject to automatic confirmation as withthe video recorded sequences.

If such immediate care or warning is not required, control then passesto step 345 where the video images are more formally captured andanalyzed for various other non-critical issues. The images may becaptured and stored locally, being provided to a central server in abatch processing, or images may be captured and sent to the remoteserver for immediate analysis and storage. Such transmission may takeplace over a well known Internet connection, wireless connection, orother proprietary communication system. Such analysis may considersuggestions to a caregiver to improve dosage accuracy, reduce pain inadministration, or the like. Furthermore, as such video sequences may beavailable from multiple patients and/or caregivers, the effectiveness ofvarious sets of instructions and the like can be tested and reviewed,and changes thereto made if consistent problems are encountered. Thistype of study is nearly impossible without the present invention,because in any type of clinical setting, individuals are far more likelyto be careful in administration of medication, and therefore not causeerrors. However, in accordance with the invention, responses toinstructions can be analyzed, and lack of adherence based upon confusingor difficult to follow instructions can be remedied, providing better ormore usable instructions, and therefore improving regimen adherence.

In any event, after such analysis, any warnings or suggestions forinstruction issues may generate a warning at step 350, suggesting areasof instruction that may be problematic. These video sequences are alsostored for longer term analysis if desired at step 355, and processingends.

It is further contemplated in accordance with the invention that thesystem and method thereof act as an overall prescription managementtool. For example, knowing the prescription and the number of actualtimes the medication has been administered, the system can orderprescriptions to be refilled and sent to the patient. Trends of apatient can be monitored, such as blood pressure or other measurablequantities of the patient, and correlation between such measuredquantities and medication administration may be observed, potentiallyallowing for a more customized solution of medication to be applied tothe patient, possible modifying dosage or frequency of administrationbased upon individual reactions to a particular prescription regimen.Further, insurance administration can be simplified by providing theprescription information directly to the insurance company, and allowingreimbursement for patient costs and other billing issues to be takencare of over a computer network, by phone or the like. Additionally,features of the invention noted above allowing for user interaction andrecordation of activities of a user, adverse effects and the like may beincorporated into the system to provide further information fordetermining alternative instruction sets, modification of medicationsand the like.

A system provided in accordance with the invention includes imagingtechnology and hardware, communication hardware, computer systemsincluding storage memory and remote communication via the Internet orother communication network for remote storage and analysis, databasesof patient information and medication information sufficient toimplement the method as described above.

Therefore, in accordance with the invention, a method and system areprovided that allow for the automated administration of medication, andprovide for a most sophisticated method for confirming and studyingmethods of administration of such prescription medication.

It will thus be seen that the objects set forth above, among those madeapparent from the preceding description, are efficiently attained and,because certain changes may be made in carrying out the above method andin the construction(s) set forth without departing from the spirit andscope of the invention, it is intended that all matter contained in theabove description and shown in the accompanying drawings shall beinterpreted as illustrative and not in a limiting sense.

It is also to be understood that this description is intended to coverall of the generic and specific features of the invention hereindescribed and all statements of the scope of the invention which, as amatter of language, might be said to fall there between.

1-20. (canceled)
 21. A computer-implemented method of determining userresponse to administration of medication, the method comprising:obtaining information identifying a medication prescription regimen;determining one or more procedures for administering the medicationprescription regimen, including ingestion of the medication; capturing,by a video capture device, one or more video activity sequences ofactual administration by a user in accordance with the one or moreprocedures, including during a time period after the ingestion of themedication; storing the one or more video activity sequences to anon-transitory, computer-readable storage medium; analyzing at least oneof the one or more video activity sequences to identify actionsperformed by the user after the ingestion of the medication; based onthe actions performed by the user after the ingestion of the medication,identifying an adverse reaction to the medication; and providing anotice to a third party in response to identifying the adverse reaction.22. The computer-implemented method of claim 21, wherein providing thenotice to the third party comprises automatically triggering at leastone of a re-ordering of medication by a pharmacy or medical provider, adosage change, or a medication change.
 23. The computer-implementedmethod of claim 21, wherein providing the notice to the third partycomprises automatically triggering contact with the user by a medicalprofessional.
 24. The computer-implemented method of claim 21, whereinthe notice to the third party comprises a recommendation of proposedchanges in the medication prescription regimen.
 25. Thecomputer-implemented method of claim 21, wherein the actions performedby the user comprise at least one of facial gestures, lack of motion,fainting, falling down, or gastrointestinal distress.
 26. Thecomputer-implemented method of claim 21, comprising obtaining the one ormore procedures for administering the medication prescription regimenfrom a database.
 27. The computer-implemented method of claim 21,comprising: retrieving medical history information of the user; anddetermining whether the medication is safe for the user.
 28. Thecomputer-implemented method of claim 21, wherein the one or moreprocedures for administering the medication prescription regimen aremodified by a medical professional.
 29. A system for determining userresponse to administration of medication, the system comprising: anon-transitory, computer-readable storage medium; a video capturedevice; a remote communication module; and a computer system configuredto perform operations comprising: obtaining information identifying amedication prescription regimen; determining one or more procedures foradministering the medication prescription regimen, including ingestionof the medication; capturing, by the video capture device, one or morevideo activity sequences of actual administration by a user inaccordance with the one or more procedures, including during a timeperiod after the ingestion of the medication; storing the one or morevideo activity sequences to the non-transitory, computer-readablestorage medium; analyzing at least one of the one or more video activitysequences to identify actions performed by the user after the ingestionof the medication; based on the actions performed by the user after theingestion of the medication, identifying an adverse reaction to themedication; and providing, by the remote communication module, a noticeto a third party in response to identifying the adverse reaction. 30.The system of claim 29, wherein providing the notice to the third partycomprises automatically triggering at least one of a re-ordering ofmedication by a pharmacy or medical provider, a dosage change, or amedication change.
 31. The system of claim 29, wherein providing thenotice to the third party comprises automatically triggering contactwith the user by a medical professional.
 32. The system of claim 29,wherein the notice to the third party comprises a recommendation ofproposed changes in the medication prescription regimen.
 33. The systemof claim 29, wherein the actions performed by the user comprise at leastone of facial gestures, lack of motion, fainting, falling down, orgastrointestinal distress.
 34. The system of claim 29, comprising aremote database, wherein the operations comprise obtaining the one ormore procedures for administering the medication prescription regimenfrom the remote database.
 35. The system of claim 29, wherein theoperations comprise: retrieving medical history information of the user;and determining whether the medication is safe for the user.
 36. Thesystem of claim 29, wherein the one or more procedures for administeringthe medication prescription regimen are modified by a medicalprofessional.